Simcyp PBPK Modeling and Simulation

A recent FDA draft guidance for industry, “Physiologically-based pharmacokinetic analyses—format and content” highlights the regulatory currency that PBPK now garners:

“Throughout a drug’s life cycle, PBPK model predictions can be used to support decisions on whether, when, and how to conduct certain clinical pharmacology studies, and to support dosing recommendations in product labeling.”

The Simcyp Difference

Most of the top-40 pharmaceutical companies (including all of the top 10), along with the major regulatory bodies (FDA, EMA, PMDA) are members of the Simcyp® Consortium, which uses Certara’s Simcyp Simulator PBPK modeling and simulation platform to select the most appropriate drug doses, design optimal clinical trials, evaluate new drug formulations, and predict drug-drug interactions (DDIs) and PK outcomes in clinical populations. Simcyp Simulator models are used extensively to inform drug label claims.